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Medication Management and Care of Demented Patients With Behavioral and Psychological Symptoms of Dementia in Taiwan: A Retrospective Pilot Study

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01303367
First Posted: February 24, 2011
Last Update Posted: February 24, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Taipei Medical University WanFang Hospital
  Purpose
U.S. Food and Drug Administration (FDA) and other countries issue warnings on the off-label use of antipsychotics in demented patients with behavioral and psychological symptoms of dementia (BPSD) (FDA warning, 2003; 2005; 2008). There is a significant increase in mortality rate by 1.6 fold due to cardiovascular events and aspiration pneumonia in the demented patients received antipsychotics comparing to placebo group. However, the prescription rates of antipsychotics in demented patients are still increased by 20% after several alerts in Canada (Valiyeva et al., 2008).

Condition
Dementia

Study Type: Observational
Study Design: Time Perspective: Retrospective
Official Title: Medication Management and Care of Demented Patients With Behavioral and Psychological Symptoms of Dementia in Taiwan: A Retrospective Pilot Study

Resource links provided by NLM:


Further study details as provided by Taipei Medical University WanFang Hospital:

Enrollment: 200
Study Start Date: January 2002
Study Completion Date: December 2010
Groups/Cohorts
antipsychotic agents
non-antipsychotic agents

Detailed Description:

Cumulative observations indicate that demented patients withdrawn antipsychotics may not exacerbate BPSD. The DART-AD study shows that both demented patients with/without antipsychotics for six months have no significant difference in cognitive symptoms and BPSD (Ballard et al., 2008). Moreover, the results of a long-term follow-up DART-AD study demonstrate that the survival rate of demented patients with antipsychotics is lower than those without antipsychotics at 24th month (with group vs. without group = 40% vs. 71%) and 36th month (with group vs. without group = 30% vs. 59%), respectively (Ballard et al., 2009). Recently, several studies indicate that antidepressants such as citalopram and milnacipran might be a new medication management for demented patients with BPSD (Pollock et al., 2007).

The present study is designed as a retrospective open-label pilot study. The initial research goal of this study is to determine the prevalence of psychotropic agents in demented patients in Taiwan National Health Insurance Research Database (NHIRD) (2005 v.s. 2008) and prescription rates of psychotropic agents in demented patients in Taipei Medical University-Teaching Hospitals (from 2002 to 2010). The psychotropic agents are defined as antipsychotic, antidepressant, sedative-hypnotic, anticonvulsant agents. Moreover, the second objective of this study is to investigate the risk of cardiovascular and aspiration pneumonia. Finally, the results of this study could be used to create the best and practical protocol of treatment for BPSD in demented patients of Taiwan to improve their drug safety and quality of life.

Currently, there is no treatment for BPSD, and pharmacists should recommend physicians to decrease the off-label use of antipsychotics in demented patients with BPSD. The main reason is due to the fact that off-label use of antipsychotics increases significantly the mortality rate of demented patients. The therapeutic management of BPSD should be based on the evidence-based medicine and patient safety.

  Eligibility

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
dementia patients
Criteria

Inclusion Criteria:

  • This study is planning to study patients with dementia (ICD-code: 290.XX), Alzheimer's disease (ICD-code: 331.0), and/or other organic psychotic conditions (chronic) (ICD-code: 294.XX), including delirium, delusion, depressive features, and/or in conditions classified elsewhere with behavior disturbance.
  • This study is to include demented patients with mild to moderate cognitive impairment (mini-mental state examination [MMSE] = 10-24/ Clinical Dementia Rating [CDR] = 0.5-2).

Exclusion Criteria:

  • The present proposal excludes patients with a primary history of schizophrenic disorder (ICD-code: 295XX) and bipolar disorder (296XX).
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01303367


Locations
Taiwan
Taipei Medical University - WanFang Hospital
Taipei, Taiwan
Sponsors and Collaborators
Taipei Medical University WanFang Hospital
Investigators
Principal Investigator: Winston Wu-Dien Shen Taipei Medical University WanFang Hospital
  More Information

Responsible Party: Winston Wu-Dien Shen, Department of Psychiatric, WanFang Hospital
ClinicalTrials.gov Identifier: NCT01303367     History of Changes
Other Study ID Numbers: 99076
First Submitted: February 22, 2011
First Posted: February 24, 2011
Last Update Posted: February 24, 2011
Last Verified: February 2011

Keywords provided by Taipei Medical University WanFang Hospital:
Dementia
behavioral and psychological symptoms of dementia

Additional relevant MeSH terms:
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders